CompletedPhase 4ACTRN12612000394842
An evaluation of prednisolone to treat viral associated wheeze in pre-school aged children.
A prospective, randomised, double blinded, non-inferiority trial assessing the impact of oral prednisolone on hospital length of stay in pre-school aged children presenting with viral associated wheeze.
Sponsor
Dr Steven Foster - ED Fellow
Enrollment
700 participants
Start Date
Jun 11, 2012
Study Type
Interventional
Conditions
Summary
This clinical trial is designed to test whether oral corticosteroids are effective in treating children of pre-schol age presenting with wheeze associated with viral upper respiratory tract illness.
Eligibility
Sex: Both males and femalesMin Age: 24 MonthssMax Age: 72 Monthss
Inclusion Criteria2
- Clinical diagnosis of wheeze.
- Presence of symptoms or signs of an intercurrent or recent (within 72hrs) viral upper respiratory tract infection.
Exclusion Criteria13
- Presenting oxygen saturation (SpO2) less than 92% in room air.
- Features of "critical wheeze" - (silent chest on auscultation and/or exhaustion with or without cyanosis)
- Clinical evidence of shock or bacterial sepsis.
- Active varicella infection.
- High clinical suspicion of alternative diagnosis for wheeze (for example - inhaled foreign body).
- Previous PICU admission with wheeze / asthma.
- Premature birth - defined as <34 weeks gestation.
- Known cardiac / other respiratory disease.
- Recieving immunosuppresant therapy or known to have immunodeficiency.
- Upper respiratory tract structural abnormality.
- Oral corticosteroid therapy within the last 14 days.
- Previously recruited to this study.
- Known allergy to Prednisolone.
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Interventions
Oral prednisolone 1mg/kg once daily for 3 days.
Oral prednisolone 1mg/kg once daily for 3 days.
Locations(1)
View Full Details on ANZCTR
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ACTRN12612000394842